FDA.reportPublic FDA data

Castor Oil

Product NDC
11344-078
11-digit product format
113440078
Labeler code
11344
Product ID
11344-078_4b30e38e-4b06-2bda-e063-6294a90a2b41
Type
HUMAN OTC DRUG
Nonproprietary name
Castor Oil
Dosage form
LIQUID
Route
ORAL
Labeler
Nice-Pak Products, LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-12-09
Substance
CASTOR OIL
Active strength
1 g/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct11344-078IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage11344-07811344-078-26IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Castor Oil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CASTOR OIL1 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D5340Y2I9GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204691Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff6c8022-9522-4eae-b8ff-994ee37fba06Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11344-078-262020-06-23C16284748780-19d75b9d0-a168-f424-e053-dadaa90a57ceGood Sense 078.000/078AA Castor Oil
11344-078-262020-01-31C16284748780-19d75b9d0-a168-f424-e053-dadaa90a57ceGood Sense 078.000/078AA Castor Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11344-078-26Castor Oil118 mL in 1 BOTTLE, PLASTICLIQUID11815

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11344-078-26ML - Milliliter11344-0789d999d2d-a141-4174-b76a-17f99aeb4d2112022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-078CASTOR OIL LIQUID [CONSUMER PRODUCT PARTNERS, LLC]13Current NDC, Legacy NDC, 1 package rows20240314_ff6c8022-9522-4eae-b8ff-994ee37fba06.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 34 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGProficient Rx LP8678a3ee-0e2c-4c95-ad2e-83aa601f32382024-10-01WarningsExact identifier
application number: M007
Pedia-LaxDOCUSATE SODIUMC.B. Fleet Company, Inc.0e908bea-ebab-44e7-919c-90002e6f5d422024-10-01WarningsExact identifier
application number: M007
Natural Vegetable Laxative and Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESBETTER LIVING BRANDS LLC.f2c562e1-4080-44cb-e053-2a95a90a42222024-09-25WarningsExact identifier
application number: M007
SENNA-S LAXATIVE WITH STOOL SOFTENERSENNOSIDESBasic Drugs, Inc.d32b9956-fc04-8d64-e053-2a95a90a17b32024-09-14WarningsExact identifier
application number: M007
DOCUSATE SODIUM, EXTRA STRENGTH 250 MGDOCUSATE SODIUMAdvanced Rx LLCe8be12c5-c591-eadd-e053-2a95a90a431b2024-09-13WarningsExact identifier
application number: M007
SennaSENNOSIDESProficient Rx LP5f7f0df4-dabe-4c8f-a2b5-766f20af2f462024-09-01WarningsExact identifier
application number: M007
Fiber caplets 147CALCIUM POLYCARBOPHILChain Drug Marketing Association Inc.17e2a50d-1867-49fe-e063-6394a90a56df2024-08-27WarningsExact identifier
application number: M007
MAXIMUM STRENGTH LAXATIVE PILLSSENNOSIDESTARGET CORPORATION7cae52ae-931c-3e7c-e053-2991aa0a83962024-08-22WarningsExact identifier
application number: M007
STOOL SOFTENER AND STIMULANT LAXATIVEDOCUSATE SODIUM AND SENNOSIDESTARGET CORPORATION7cac99da-8d89-0aee-e053-2991aa0a0fd92024-08-22WarningsExact identifier
application number: M007
SENNA LAXATIVESENNOSIDES 8.6 MGTARGET CORPORATION7cab058f-3647-7124-e053-2a91aa0a41bd2024-08-22WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMPadagis Israel Pharmaceuticals Ltdbce3b245-ec47-4e62-9cad-bb12d0812c182024-08-15WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.56f7966a-c95e-3ce3-e054-00144ff88e882024-08-14WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMProficient Rx LPccfa095c-77f0-41ff-84f8-e02d983c7c742024-08-01WarningsExact identifier
application number: M007
Magnesium CitrateHARRIS TEETER MAGNESIUM CITRATE ORAL SOLUTION - LEMONHarris Teeter, LLC1e8e01fc-2c89-9722-e063-6394a90a6acf2024-07-31WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESBest Choice (Valu Merchandisers Company)d5f90aa1-78e5-491f-b09d-399d54f3def12024-07-31WarningsExact identifier
application number: M007
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESWalgreensdb528659-768a-46e0-a340-9fbcdb25ea5e2024-07-25WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESWalgreensbfa089a6-4767-45e0-b663-ee7e8949d9a42024-07-25WarningsExact identifier
application number: M007
Dr. FibraPSYLLIUM HUSKPharmadel LLC1a6151c9-e1c4-f0c1-e063-6394a90aad242024-07-22WarningsExact identifier
application number: M007
BISACODYLBISCODYLTARGET CORPORATION8ed281d5-b17e-e3bb-e053-2995a90a25902024-07-15WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE CALCIUMWalgreensb6f0770e-671d-4965-9275-b1c224d7f06a2024-07-10WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204691castor oil 100 % Oral SolutionPSNff6c8022-9522-4eae-b8ff-994ee37fba0615
204691castor oil 1000 MG/ML Oral SolutionSCDff6c8022-9522-4eae-b8ff-994ee37fba0615
204691castor oil 100 % Oral SolutionSYff6c8022-9522-4eae-b8ff-994ee37fba0615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11344-078-2611344007826118 mL in 1 BOTTLE, PLASTIC (11344-078-26) 118 ml2008-12-090000-00-00NoNoCurrent